Review Panel
Physical Medicine FDA 510(k) Clearances & Devices
- Cleared Devices
- 5,661
- Product Codes (page)
- 19
- Latest Decision
- 2024-05-16
Clearances · page 4 of 57
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K232786 | Stimulation System (PA series, PR series, S series and Q series) | Edan Instruments, Inc. | IPF | Class II | 2024-05-16 |
| K233695 | Medical HAL Lower Limb Type (HAL-ML) | Cyberdyne, Inc. | PHL | Class II | 2024-05-07 |
| K240012 | Mobility Scooter (W3431) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2024-05-02 |
| K240986 | Cold Compression | Jkh Health Co., Ltd. | IRP | Class II | 2024-05-01 |
| K232181 | Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) | Hebei JT Medical Co., Ltd. | NGX | Class II | 2024-04-24 |
| K234098 | Mobility Scooter (C4+) | Yongkang Yile Vehicle Co., Ltd. | INI | Class II | 2024-04-18 |
| K232409 | Electromagnetic Stimulation Systems | Shanghai Apolo Medical Technology Co., Ltd. | NGX | Class II | 2024-04-10 |
| K240329 | Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F) | Yongkang Youha Electric Appliance Co., Ltd. | ITI | Class II | 2024-03-25 |
| K240122 | Normatec Elite | NormaTec Industries, LP | IRP | Class II | 2024-03-21 |
| K233926 | accufit | Mettler Electronics Corporation | IPF | Class II | 2024-03-21 |
| K233070 | Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) | Chongqing Rob Linka Science and Technology Co., Ltd. | NGX | Class II | 2024-03-13 |
| K231789 | Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) | Guangzhou Xinbo Electronic Co., Ltd. | NGX | Class II | 2024-03-11 |
| K233877 | XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) | Magic Mobility | ITI | Class II | 2024-03-04 |
| K222400 | Coresculpt & Magsculpt | K1Med Co., Ltd. | NGX | Class II | 2024-02-27 |
| K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | ITH | Class II | 2024-02-22 |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | OAP | Class II | 2024-02-07 |
| K233485 | M-Wave | Zynex Medical, Inc. | IPF | Class II | 2024-01-26 |
| K230524 | Cold Compression Wrap Pro | Chengdu Cryo-Push Medical Technology Co.,Ltd | IRP | Class II | 2024-01-19 |
| K232783 | Power wheelchair (Model: JMPW-01W) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | ITI | Class II | 2024-01-19 |
| K231315 | Velox Power Chair | Velox Manufacturing, Inc. | ITI | Class II | 2024-01-12 |
| K233035 | Electronic Muscle Stimulator (Model MP01) | Shenzhen Hengbosi Industrial Co., Ltd. | NGX | Class II | 2024-01-08 |
| K232937 | BTL-899M | BTL Industries, Inc. | IPF | Class II | 2023-12-26 |
| K223729 | FLOWpresso | Medella Health Limited | IRP | Class II | 2023-12-21 |
| K233492 | EMS Neck Massager | Xiamen Comfier Technology Co., Ltd. | NGX | Class II | 2023-12-20 |
| K233470 | DEKA LILY | El.En S.P.A. | NGX | Class II | 2023-12-19 |
| K233536 | Air Compression Recovery System | Shenzhen Dongjilian Medical Tech Co., Ltd. | IRP | Class II | 2023-12-16 |
| K230964 | Power Wheelchair (N5909) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2023-12-13 |
| K232077 | Atalante X | Wandercraft SAS | PHL | Class II | 2023-12-13 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | IPF | Class II | 2023-11-24 |
| K231508 | Power Wheelchair, W5521 | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | ITI | Class II | 2023-11-09 |
| K231440 | Combo Electrotherapy Device | Shenzhen Roundwhale Technology Co. , Ltd. | IPF | Class II | 2023-11-03 |
| K231868 | Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | 2023-10-31 |
| K223541 | Cold/Hot Compression | Jkh Health Co., Ltd. | IRP | Class II | 2023-10-27 |
| K230500 | Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) | Jiangsu Maxf Electric Appliance Co., Ltd. | IRP | Class II | 2023-10-26 |
| K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC | PFW | Class II | 2023-10-25 |
| K232356 | Laser Cap, Model: Hat-01 | Hubei Yjt Technology Co.,Ltd | OAP | Class II | 2023-10-24 |
| K230472 | Sonopuls 190 | Enraf-Nonius, B.V. | IMI | Class II | 2023-10-24 |
| K232020 | Iontophoresis Electrodes | Top-Rank Health Care Co., Ltd. | EGJ | Class II | 2023-10-16 |
| K223027 | NeuroTrigger Basic (NTB) | Neurotrigger | IPF | Class II | 2023-10-10 |
| K223802 | accufit | Mettler Electronics Corporation | IPF | Class II | 2023-10-06 |
| K232230 | YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2023-10-03 |
| K221274 | StarFormer, TightWave | Fotona D.O.O. | IPF | Class II | 2023-09-29 |
| K232193 | Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) | Yurob Rehabilitation Medical Co., Ltd. | ITI | Class II | 2023-09-22 |
| K232121 | Power wheelchair (Model:BC-EA8000) | Ningbo Baichen Medical Devices Co., Ltd. | ITI | Class II | 2023-09-15 |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2023-09-15 |
| K232198 | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2023-09-15 |
| K230167 | BACK 4 | Swims America Corp | IPF | Class II | 2023-09-14 |
| K230024 | HI-EMT MAGSHAPE | Beijing Sano Laser S&T Development Co.,Ltd | NGX | Class II | 2023-09-06 |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC | IOR | Class I | 2023-09-05 |
| K201869 | Ki Power Tilt System | Ki Mobility, LLC | ITI | Class II | 2023-09-05 |
| K232334 | DEKA SIMON | El.En S.P.A. | IPF | Class II | 2023-09-01 |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | IOR | Class I | 2023-08-31 |
| K223533 | Little Wave Arc; Little Wave Flip | Ki Mobility, LLC | LBE | Class I | 2023-08-31 |
| K220938 | Nova HD+ | Aura Wellness, LLC | NGX | Class II | 2023-08-22 |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | IOR | Class I | 2023-08-15 |
| K231409 | Erchonia FX-405 | Erchonia Corporation | NHN | Class II | 2023-08-11 |
| K231321 | Nooance Led And Laser Helmet | Shenzhen Kaiyan Medical Equipment Co., Ltd. | OAP | Class II | 2023-07-31 |
| K231912 | Therm-X | Zenith Technical Innovations | IRP | Class II | 2023-07-27 |
| K231472 | Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) | Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. | INI | Class II | 2023-07-19 |
| K231437 | LF900 | Daesung Maref Co., Ltd. | IRP | Class II | 2023-07-19 |
| K231428 | Mobility Scooter (Models: W3431D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2023-07-14 |
| K231318 | Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) | Beijing Adss Development Co., Ltd. | NGX | Class II | 2023-07-07 |
| K230001 | Electric Scooter (Model: M2020) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | 2023-07-05 |
| K231153 | Neuhat Hair Growth System; ibeauty.com Laser Cap | Nature, Inc.redible, Inc. | OAP | Class II | 2023-06-23 |
| K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | PFW | Class II | 2023-06-23 |
| K231136 | Fitness Belt (Model: KLT-07) | Shenzhen Kelutongda Industrial Co., Ltd. | NGX | Class II | 2023-06-16 |
| K231110 | Manual Wheelchair (A006) | Ningbo Shenyu Medical Equipment Co.,Ltd | IOR | Class I | 2023-06-16 |
| K222790 | F65 Laser System | Lumenis Be, Ltd. | OAP | Class II | 2023-06-14 |
| K231368 | Bemer Therapy System Evo | Bemer Int AG | NGX | Class II | 2023-06-09 |
| K230261 | Gnesis EMS Plus | Creative Fitness Developments S.L. | NGX | Class II | 2023-06-06 |
| K231320 | Zhenjiang Assure Mechanical Wheelchair,model:K1 | Zhenjiang Assure Medical Equipment Co., Ltd. | IOR | Class I | 2023-06-05 |
| K223620 | Reprieve by RegenesisTM | Regenesis Biomedical, Inc. | IMJ | Class II | 2023-05-24 |
| K230134 | Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 | Hubei Yjt Technology Co.,Ltd | OAP | Class II | 2023-05-23 |
| K222703 | ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) | Moving Life, Ltd. | INI | Class II | 2023-05-19 |
| K222912 | c1Trac | Zimmer Medizinsysteme GmbH | ITH | Class II | 2023-05-16 |
| K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) | Mmj Labs, LLC | PHW | Class I | 2023-05-15 |
| K231032 | AMP by Method Mobility, AMP Plus (or +) by Method Mobility | Method Mobility | ITI | Class II | 2023-05-10 |
| K230615 | Electric Scooter (Model: S3312) | Guangdong Prestige Technology Co., Ltd. | INI | Class II | 2023-05-05 |
| K230597 | Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) | Light Tree Ventures Europe B.V. | OAP | Class II | 2023-04-28 |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | Wontech Co., Ltd. | OAP | Class II | 2023-04-28 |
| K221865 | BTL-094 | BTL Industries, Inc. | ISA | Class I | 2023-04-14 |
| K230336 | CurrentBody Skin Led Hair Regrowth(Model: MZ-07) | Light Tree Ventures Europe B.V. | OAP | Class II | 2023-04-05 |
| K230385 | Ballancer Platinum (1222) | Mego Afek | IRP | Class II | 2023-04-04 |
| K222729 | Electrical Scooter, WT-T4QP2 | WuS Tech Co., Ltd. | INI | Class II | 2023-03-28 |
| K223393 | Electric Wheelchair | Shanghai Bangbang Robotics Co., Ltd. | ITI | Class II | 2023-03-16 |
| K222991 | Air Compression Leg Massager (model: EMK-701) | Xiamen Emoka Health Science & Technology Co., Ltd. | IRP | Class II | 2023-03-15 |
| K223464 | Leg and Foot Air Wave Pressure Therapy Device | Zhangzhou Easepal Innovation CO , Ltd. | IRP | Class II | 2023-03-14 |
| K223642 | LED Lip Perfector, model: ZC-05 | Light Tree Ventures Europe B.V. | ILY | Class II | 2023-03-09 |
| K222875 | Powered Muscle Stimulator (Model name:MagGraver F200) | Nanjing Vishee Medical Technology Co., Ltd. | NGX | Class II | 2023-03-09 |
| K222098 | ManaSport+ | Manamed, Inc. | IMI | Class II | 2023-03-08 |
| K222136 | Cryo-Thermo Compression Device (FGK002) | Suzhou Microport Rehabtech (Group) Co., Ltd. | IRP | Class II | 2023-03-08 |
| K221696 | ReWalk P6.0 | Re Walk Robotics , Ltd. | PHL | Class II | 2023-03-02 |
| K222507 | Mobility Scooter (Models: W3431Q, W3431R) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | INI | Class II | 2023-02-28 |
| K222386 | Visionbody | Vb Technologies AG | NGX | Class II | 2023-02-24 |
| K223797 | Neuro20 Pro System | Neuro20 Technologies | NGX | Class II | 2023-02-23 |
| K223492 | eFOLDi Scooter, Lite | Suntech UK , Ltd. | INI | Class II | 2023-02-22 |
| K220698 | Bambino 3, S3 and S3 Swing, U3 and U3 Light, X | Panthera AB | IOR | Class I | 2023-02-16 |
| K221200 | XBody Go USA, XBody Pro USA | Xbody Hungary Kft. | NGX | Class II | 2023-01-31 |
| K210166 | Omnispec ED1000 | Medispec, Ltd. | ISA | Class I | 2023-01-27 |
| K222818 | Xpedition Powered Stair Chair (625700000000) | Stryker Medical | ILK | Class II | 2023-01-24 |
5,661 clearances in the Physical Medicine panel. Data: openFDA.